The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

8876–8900 of 53036

  • HighFDA (Devices)·Z-1805-2024·2024-05-22

    Medtronic Venous Cannulae Recalled for Unsealed Sterile Packaging

    Medtronic Perfusion Systems is recalling 17,221 units of venous cannulae due to potential for unsealed sterile packaging. The devices were distributed worldwide to healthcare facilities.

    Product
    Medtronic Venous Cannulae: a) DLP¿ 20 Fr. Malleable Single Stage Venous Cannula, Model Number 68120, b) DLP¿ 24 Fr. Malleable Single Stage Venous Cannula, Model Number 68124, c) DLP¿ 28 Fr. Malleable Single Stage Venous Cannula, Model Number 68128, d) DLP¿ 30 Fr. Malleab
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1829-2024·2024-05-22

    MRI System Software May Fail to Warn of Inadequate Ventilation

    Philips Ingenia 1.5T MRI systems with software R5.7.1 may not provide adequate warning for low ventilation conditions, potentially causing increased patient body temperature or burning sensation.

    Product
    Ingenia 1.5T with Evolution Upgrade 1.5T - Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device REF: 782116
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1809-2024·2024-05-22

    Karl Storz Laser Surgical Instruments Recalled Due to Sterilization Concerns

    Karl Storz laser surgical instruments lack validated sterilization procedures, creating infection risk after reprocessing. The FDA has recalled 85 units distributed nationwide and in Argentina.

    Product
    LASER Application Instrument, 23 cm, REF: 8694; LEUNIG-GREVERS LASER Application, REF: 461000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1799-2024·2024-05-22

    Medtronic Vessel Cannulae Recalled for Potential Unsealed Sterile Packaging

    Medtronic is recalling 5,719 vessel cannulae units due to potential for unsealed sterile packing, affecting worldwide distribution.

    Product
    Medtronic Vessel Cannulae: a) DLP¿ 2 mm Vessel Cannula Blunt Tip, Model Number 30004; b) DLP¿ 3 mm Vessel Cannula Blunt Tip, Model Number 30003
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1831-2024·2024-05-22

    CARDIOHELP-i System Recalled for Elevated Patient Leakage Current

    Maquet Medical Systems USA is recalling the CARDIOHELP-i System because measured patient leakage current in some units significantly exceeded expected safety levels.

    Product
    CARDIOHELP-i System. Blood oxygenation and carbon dioxide removal system.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1826-2024·2024-05-22

    Sophysa Pressio Ventricular ICP Monitoring Kit Recalled for Manufacturing Defect Causing CSF Leakage

    Sophysa is recalling the Pressio Ventricular Intracranial Pressure Monitoring Kit due to a manufacturing defect that causes cerebrospinal fluid leakage. An undetected leak during implantation could pose an infectious risk to patients.

    Product
    The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitoring is intended for monitoring intracranial ventricular pressure and temperature with tunneling (PSO-VTT) indicated for use in intraventricular pressure monitoring and cerebrospinal fluid drainage applic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1790-2024·2024-05-22

    Prosthetic Knee Firmware Defect Risks Unintended Shutdown and Patient Falls

    The RKNXC0005 RHEO KNEE XC prosthetic knee may experience firmware issues causing unintended warnings and device shutdown, creating a fall risk for patients.

    Product
    RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic component
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1827-2024·2024-05-22

    Philips Patient Information Center iX Software: Event Catalog Data Loss Recall

    Philips Patient Information Center iX software version 4.x fails to properly save or transfer event catalog information, risking data loss in healthcare facilities. The FDA issued a Class II recall affecting 358 units globally.

    Product
    Patient Information Center iX and Patient Information Center iX Expand, Software Version 4.x.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1804-2024·2024-05-22

    Medtronic Suction Tubes Recalled for Potential Unsealed Sterile Packaging

    Medtronic is recalling multiple models of suction tubes due to potential for unsealed sterile packing, which could compromise device sterility. Affected customers should refer to the official FDA recall notice for lot details.

    Product
    Medtronic Suction Tubes: a) DLP¿ Suction Tube 6-Fr. Shaft with Frazier Tip, Model Number: 10050, b) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10052, c) DLP¿ Suction Tube 6-Fr. Shaft with 10-Fr. Soft Tip, Model Number: 10053, d) DLP¿ Suction Tube
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1832-2024·2024-05-22

    EchoTip Ultra HD Endoscopic Ultrasound Access Needle recalled for elevated bacterial endotoxin

    Cook Medical has recalled EchoTip Ultra HD Endoscopic Ultrasound Access Needles (lots C2145003, C2144407) due to elevated levels of bacterial endotoxin. The devices were distributed internationally in Germany, Netherlands, Switzerland, and the United Kingdom.

    Product
    EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1243-2024·2024-05-22

    Sysco Classic Riced Cauliflower Recalled for Listeria Contamination

    CN Frozen Foods is recalling Sysco Classic Riced Cauliflower sold in Texas due to Listeria monocytogenes contamination detected during testing. No illnesses have been reported.

    Product
    Sysco Classic Riced Cauliflower packed in a 4lb plastic bag (6 units of 4 lb. per carton box).
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1803-2024·2024-05-22

    Medtronic Intracoronary Shunts recalled for potential unsealed sterile packaging

    Medtronic Intracoronary Shunts may have compromised sterile packaging, potentially allowing contamination. The FDA Class II recall affects 1,410 units distributed worldwide.

    Product
    Medtronic Intracoronary Shunts: a) ClearView¿ 1.00 mm Intracoronary Shunt, Model Numbers: 31100; b) ClearView¿ 1.25 mm Intracoronary Shunt, Model Numbers: 31125; c) ClearView¿ 2.00 mm Intracoronary Shunt, Model Numbers: 31200
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1240-2024·2024-05-22

    Savor Spicy Mango Slices Recalled Due to Undeclared Soy

    Savor brand Spicy MANGO slices are being recalled because they contain undeclared hydrolyzed soy protein, a common allergen. Consumers with soy allergies should not consume this product.

    Product
    Savor brand Spicy MANGO slices; net weight 8.0 oz. (227 grams)
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1806-2024·2024-05-22

    MEDLINE namic Cardiovascular Kit Variants Recalled for Lack of Sterility

    Medline Industries recalls multiple namic CONVENIENCE KIT variants used in cardiovascular procedures due to lack of sterility assurance. Approximately 570 units distributed nationwide may pose infection risk.

    Product
    namic CONVENIENCE KIT, a) CAROTID MANIFOLD KIT, REF 60011045; b) 3V MANIFOLD KIT ON WITH NAMIC DT & WASTE MANAGEMENT, REF 60070582; c) LEFT HEART KIT, REF 60071822; d) LEFT HEART KIT, REF 60080085; e) CONVENIENCE KIT, REF 60100055; f) CONVENIENCE KIT, REF 60101041;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1798-2024·2024-05-22

    Medtronic Tourniquet Sets recalled for potential unsealed sterile packing

    Medtronic is recalling 1760 tourniquet kits due to potential for unsealed sterile packing. These surgical devices may have compromised sterilization barriers.

    Product
    Medtronic Tourniquet Sets: a) DLP¿ 5.5 in (14.0 cm) Tourniquet Kit, Model Number 79004, b) DLP¿ 7 in (17.8 cm) Tourniquet Kit, Model Number 79009
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1835-2024·2024-05-22

    Cardinal Health Curity Adhesive Bandages Recalled for Latex Contamination

    Cardinal Health is recalling Curity Flexible Adhesive Bandages (Model 44102, Lot #A14722) due to potential contamination with latex adhesive residual. The hypoallergenic product was distributed nationwide to approximately 2,000 packages.

    Product
    CardinalHealth Curity Flexible Adhesive Bandage X-Large 2 x 3.75 in. (5.1 x 9.5 cm), Model 44102, Sterile, Hypoallergenic.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1800-2024·2024-05-22

    Medtronic Aortic Root Cannulae and Cardioplegia Needles Recalled for Unsealed Sterile Packing

    Medtronic is recalling aortic root cannulae and cardioplegia needles used in cardiac surgery due to potential unsealed sterile packaging. Approximately 2,622 units were distributed worldwide.

    Product
    Medtronic Aortic Root Cannulae and Cardioplegia Needles: a) DLP¿ 9 Ga (11 Fr) Aortic Root Cannula, Model Number 24009; b) DLP¿ 16 Ga (5 Fr) Cardioplegia Needle Neonatal 0.64 cm (1/4 in) Tip Length, Model Number 11316; c) M+AR" 14 Ga (7 Fr) Aortic Root Cannula with Flow-
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1242-2024·2024-05-22

    Canned Jalapenos Recalled Due to Glass Contamination Hazard

    M-C McLANE INTERNATIONAL is recalling canned jalapenos due to potential glass contamination. The voluntary recall affects 2991 cases distributed across 27 states.

    Product
    Jalapenos packed in 6lb 10oz cans. 6 cans per case
    Category
    Food
    Distribution
    28 states
  • HighNHTSA·24V361000·2024-05-22

    Audi Q4 e-tron built with incorrect headlight control module software

    Volkswagen is recalling certain 2022-2024 Audi Q4 e-tron and Q4 e-tron Sportback vehicles because incorrect headlight control module software may have been installed, failing FMVSS 108.

    Product
    AUDI — AUDI Q4 E-TRON
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0497-2024·2024-05-22

    Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1822-2024·2024-05-22

    Novalung Sensor Box Recalled for Flow Measurement Technical Failure

    Fresenius is recalling 88 Novalung sensor boxes for error messages affecting flow measurement. The defect impacts measurement capabilities in a life-support system used for acute respiratory and cardiac failure patients.

    Product
    Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long-term (> 6 hours) respiratory/ cardiopulmonary support that provides assisted extracorporeal circulation and physiologic gas exchange (oxygenation and CO2 removal) of the patient's blood in a
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1801-2024·2024-05-22

    Medtronic Cardioplegia Adapters recalled for potential unsealed sterile packaging

    Medtronic is recalling seven models of cardioplegia adapters due to potential unsealed sterile packaging, which could compromise equipment sterility in cardiac surgery. No illnesses have been reported.

    Product
    Medtronic Cardioplegia Adapters: a) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25009, b) DLP¿ 1.8 m (6 ft) Pressure Monitoring Extension Line Adapter, Model Number 25010, c) DLP¿ 30.5 cm (12 in) Multiple Perfusion Set, Model Number 14003,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1823-2024·2024-05-22

    Airvo 2 and myAirvo 2 Humidifiers: Alarm Speaker Defect Recall

    Fisher & Paykel's Airvo 2 and myAirvo 2 respiratory humidifiers have a speaker defect that may silence or distort critical alarm sounds. If the alarm fails and therapy is interrupted, patients could experience oxygen desaturation.

    Product
    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
    Category
    Medical Device
    Distribution
    Distributed nationwide